Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

A Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Manual Ventilation Alone in Patients Undergoing Non-emergent Surgery With General Anesthesia: A Prospective Randomized Cross-over Clinical Trial

Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a manual resuscitator and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this superiority study (margin 7.5 cm H20), the investigators will use a two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone with respect to airway pressure.

Inclusion Criteria:

• Adult patients who are scheduled for non-emergency surgery with general anesthesia (w/artificial airway) at Rhode Island Hospital.
• American Society Of Anesthesiologists Physical Status 1 and 2

Exclusion Criteria:

• American Society of Anesthesiologists Physical Status >3 (e.g. respiratory disease)
• Oropharyngeal or facial pathology